2026 data FDA MAUDE openFDA FDA Class II

Implant, Endosseous, Orthodontic

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §872.3640 (Dental panel).

FDA MAUDE casebook

openFDA event book Implant, Endosseous, Orthodontic LIGHT-BOOK · MAUDE

#949 of 1000 · 425 reports · 2007–2026

  • BOOK 425 reports
  • RANK #949 of 1000
  • DEATH 0 death-typed
  • INJ 409 injury-typed
  • MALF 15 malfunction
  • SPAN 2007–2026
  • PEAK 2022: 84
  • PHOTO Generator

Nearest event-volume peer: Generator, Pulsatile Flow, Cardiopulmonary Bypass (3 report gap)

Implant, Endosseous, Orthodontic sits #949 of 1000 among tracked device types with 425 MAUDE reports spanning 2007–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Implant, Endosseous, Orthodontic carries 96.2% INJURY-coded reports, 65.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 96.2% corpus 30.3% · above corpus mean (+65.9 pp)
  • MALF 3.5% corpus 64.8% · below corpus mean (-61.3 pp)

Lead product-problem code Failure to Osseointegrate is 73% of coded problems · Lead manufacturer INSTITUT STRAUMANN AG accounts for 80% of manufacturer-tagged reports · Top event location OTHER is 87% of location-tagged rows .

Implant, Endosseous, Orthodontic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Implant, Endosseous, Orthodontic carries 425 MAUDE reports, ranked #949 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 409 (96.2%)
Malfunction 15 (3.5%)
Other 1 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 401 (94.8%)
12 (2.8%)
Other 6 (1.4%)
Hospitalization 2 (0.5%)
L 1 (0.2%)
R 1 (0.2%)

Top Product Problems

Failure to Osseointegrate 329
Loose or Intermittent Connection 25
Unintended Movement 17
Break 16
Loss of Osseointegration 15
Adverse Event Without Identified Device or Use Problem 13
Fracture 12
Device Operates Differently Than Expected 5
Bent 3
Detachment of Device or Device Component 2
Insufficient Device Problem Information 2
Loose 2
Patient-Device Incompatibility 2
Compatibility Problem 1
Detachment Of Device Component 1
Device Dislodged or Dislocated 1
Device Slipped 1
Difficult to Insert 1
Dislodged 1
Explanted 1

Yearly Trend

07
2007: 2
10
2010: 1
12
2012: 3
13
2013: 2
14
2014: 4
15
2015: 28
16
2016: 12
18
2018: 1
20
2020: 38
21
2021: 68
22
2022: 84
23
2023: 78
24
2024: 44
25
2025: 39
26
2026: 21

Reports fell to 39 in 2025, down from an average of 61 in the two years before.

Related Entities for Implant, Endosseous, Orthodontic

Event Locations

OTHER 368 (86.6%)
39 (9.2%)
I 16 (3.8%)
0 1 (0.2%)
NO INFORMATION 1 (0.2%)

Compare INSTITUT STRAUMANN AG vs JJGC S.A. →

Nationwide devices with a comparable report-volume footprint

Implant, Endosseous, Orthodontic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (425 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Implant, Endosseous, Orthodontic are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Implant, Endosseous, Orthodontic; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.